1. Field of the Invention
The present invention relates to a method and apparatus for treating obesity in humans and for delivering time-release medicaments into a patient""s stomach and more particularly to a therapeutic structure which includes a plurality of space-filling portions which are sized to be received within the human patient""s body and which come together in the patient""s body to form a structure which provides therapeutic benefits.
2. Description of the Prior Art
The adverse health consequences of obesity are well known and established. It is clear that many interrelated behavioral and/or metabolic factors are at work. Consequently, it is extremely difficult for many obese people to lose weight on there own volition.
For obese patients at high risk of weight-related illness, and for the morbidly obese, there are a variety of available bariatric treatments. The most aggressive procedures are the various bariatric surgeries for reducing the stomach lumen. These surgeries include gastroplasty, gastric banding, intragastric balloons and gastric stapling. These methods can be highly effective because they severely limit the amount of food a person can ingest at one sitting, and depending upon the procedure, may induce a continual sense of satiety. Unfortunately, these surgical procedures are quite expensive. Further, the general poor health of this class of patient in combination with a major surgical procedure results in a high incidence of complications and mortality. In another approach utilizing minor surgery, an intragastric balloon can be positioned by way of permanently placed, percutaneous endoscopic gastrostomy tube. However, as with any permanent aperture made through the skin, special hygienic practices are required of the patient and complications often arise. Non-surgical bariatric procedures such as the placement of intragastric inflatable balloons via the esophagus, for example, require what is viewed to be an uncomfortable endoscopic procedure. Yet another non-surgical bariatric procedure entails wiring a patient""s jaw shut to limit food intake. However, besides being quite embarrassing and physically uncomfortable, this procedure carries an attendant risk of aspiration of vomit so patients must carry scissors or wire cutters at all times.
Outside of the discipline of bariatrics, many patients with chronic illnesses or illnesses which must be treated over a prolonged period of time (months or weeks), must remember to administer oral medicaments on a frequent and periodic schedule. Although the consequences of the disease may be serious and even life threatening, many patients find it difficult to rigorously comply with their prescribed long-term dosing regimen. A number of alternative drug delivery technologies have been developed to address this issue. Time-released oral medicaments are one alternative which can lessen the number of pills a patient must ingest daily. However, time-released medicaments normally cannot deliver a drug beyond the duration of a single digestive cycle. Transdermal patches are another alternative. However, only a subset of drugs are compatible with this method and some patients suffer adverse reactions to the adhesives employed with same. Still further, while portable automated syringes can deliver intravenous drugs over long durations, this method however, is viewed as significantly lessening the quality of life and has inherent risks. Consequently, it is typically indicated only for treating very serious illnesses.
One aspect of the present invention is to provide a method and apparatus for treating obesity that requires little or no willpower on the part of the patient, is affordable, is relatively safe, is reversible, is physically comfortable, is substantially maintenance free, and is not viewed as being socially awkward.
Another aspect of the present invention is to provide a method and apparatus for treating obesity which is operable to displace as much as 80% of a patient""s stomach lumen by the use of space-filling magnetic, biologically inert capsules which self-tessellate.
Another object of the present invention is to provide a therapeutic structure for the treatment of obesity, and for delivering time-released medicaments, which include a plurality of space-filling portions which are sized to be received within a human patient""s body, and which come together in the patient""s body to form a structure which provides therapeutic benefits for the patient.
A further aspect of the present invention is to provide a method for the treatment of obesity which includes the following steps: determining the volume of the patient""s stomach; calculating the volume of the patient""s stomach, which, if displaced, would provide medically effective weight loss; determining the number of respective space-filling portions which will form a resulting structure approximating the volume which, if displaced, would provide medically effective weight loss; providing a plurality of space-filling portions which are sized to be received within the patient""s body and which come together, following ingestion, to form a structure providing therapeutic benefits for the patient.
A further aspect of the present invention is to provide a therapeutic structure for the delivery of medicaments into a patient""s stomach, and wherein a plurality of space-filling portions are provided, and which are sized to be received within a human patient""s body, and which come together in the patient""s body to form a structure, and wherein the structure carries a medicament which is released to the patient while the structure is in the patient.
Yet a further aspect of the present invention is to provide a therapeutic structure comprising a plurality of space-filling portions which are sized to be received within a human patient""s body and which magnetically come together in a patient""s body to form the therapeutic structure, and wherein an application of a degaussing field in a given pattern to the therapeutic structure causes the therapeutic structure to disassociate thereby permitting the individual portions of the therapeutic structure to be passed out of the stomach and with the stool of the patient to ambient.
These and other aspects of the invention will be discussed in further detail below.